BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER

    MDR report key: 2881656 · Received December 12, 2012

    Report

    Report Number
    MW5028224
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ALARIS PRIMARY SET IS BEING USED WITH A BAXTER 150 ML EMPTY VAILFEX CONTAINER. ONCE SPIKED THE SET IS NEARLY IMPOSSIBLE TO REMOVE AND BOTH A NURSE AND A PHARMACIST HAVE BROKEN THE PORT FROM THE BAG TRYING TO PULL IT OUT SO A FLUSH BAG COULD BE PUT ON TO FLUSH MEDICATION OUT OF THE TUBING. DATES OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVIA CONTAINER CONTAINER KPE BAXTER UR12E1078
    2 SMARTSITE INFUSION SET INFUSION SET, 117 IN FPA ALARIS 12105747

    Patients

    Seq Age Sex Outcome Treatment
    1